Medical Design & Manufacturing 2012: WACKER Presents Special Silicones for Long-Term Medical Implants

The Munich-based WACKER Group has been developing and producing silicone rubber grades for medical applications for several years. Marketed under the SILPURAN® trademark, these products are highly pure, free of organic plasticizers and stabilizers, and have passed selected tests for biocompatibility according to ISO 10993 and US Pharmacopeia Class VI.

Munich, Oct 29, 2012
The Munich-based WACKER Group will be exhibiting at the Medical Design & Manufacturing (MD&M) Minneapolis exposition to present three new silicone product lines for medical applications: the liquid and solid silicone rubber grades SILPURAN® UR 7000 and SILPURAN® UR 9020 as well as the room-temperature-curing SILPURAN® UR 34xx. These product lines belong to a new class of SILPURAN® UR products to be presented to the public for the first time at MD&M. SILPURAN® UR is especially targeted toward long-term medical applications such as port access systems or disk and joint implants. The medical technology exposition will be held on October 31 and November 1 in Minneapolis, Minnesota, USA.

The Munich-based WACKER Group has been developing and producing silicone rubber grades for medical applications for several years. Marketed under the SILPURAN® trademark, these products are highly pure, free of organic plasticizers and stabilizers, and have passed selected tests for biocompatibility according to ISO 10993 and US Pharmacopeia Class VI. All SILPURAN® products are manufactured in accordance with WACKER’s Clean Operations Standard, and are filled and packaged under cleanroom conditions.

At MD&M, WACKER will be presenting SILPURAN® silicone rubber grades that are also suitable for long-term medical applications. Because special quality standards apply to products like these, they have been grouped together in the new SILPURAN® UR, i.e. “unrestricted” product class. The products developed for this series have also been approved for medical devices that remain in the body for longer periods of time. Potential applications cover a broad range and include port catheters, voice prostheses, gastric rings, and pacemakers through to disk, joint and hearing implants.

WACKER will be at MD&M Minneapolis to present its first three SILPURAN® UR product lines: SILPURAN® UR 7000, SILPURAN® UR 9020 and SILPURAN® UR 34xx.

  • SILPURAN® UR 7000 is a paste-like, addition-curing, liquid silicone rubber. Thanks to its short curing times, this two-part system is suitable for use in injection molding which, in turn, provides manufacturers with an economical option for mass-producing parts such as connectors, valves and seals. SILPURAN® UR 7000 is available in a variety of Shore A hardness grades and possesses considerable tear strength.
  • SILPURAN® UR 9020 has been designed for medical products subject to high levels of mechanical stress. A readily pigmentable, addition-curing solid silicone rubber, this product can be used in injection or compression molding processes, and is particularly suitable for medical and pharmaceutical molding applications. SILPURAN® UR 9020 is available in Shore A hardness grades of 30, 50 and 70. In its final form, SILPURAN® UR 9020 achieves a tear strength of up to 50 N/mm (as defined in ASTM D 624 B).
  • SILPURAN® UR 34xx is a low-viscosity, addition-curing silicone rubber suitable for use in medical applications requiring a soft compression effect. Two viscosity levels are available: 25000 mPas (SILPURAN® UR 3420) and 15000 mPas (SILPURAN® UR 3440). The product consists of an A and a B component, is easy to process and cures at room temperature.

SILPURAN® – the Ultimate in Quality and Purity

The same high quality and purity standards apply to all SILPURAN® products. Each batch is produced, inspected and documented in accordance with WACKER’s Clean Operations Standard, with 50 micrometer filtration, regular visual inspections and cleanroom dispensing/packaging processes guaranteeing the highest possible levels of product purity. Silicones in the SILPURAN® UR product line meet additional ISO 10993 and US Pharmacopeia Class VI tests for long-term applications. WACKER intends to apply for a listing of these products in the corresponding FDA device master files as approved materials for medical implants.

Contact

Wacker Chemie AG
Media Relations & Information
Florian Degenhart

Tel. +49 89 6279-1601
Fax +49 89 6279-2877
Email florian.degenhart@wacker.com